EP2484404B1 - Procédé de fabrication pour gaine d'accès résistante au coudage - Google Patents

Procédé de fabrication pour gaine d'accès résistante au coudage Download PDF

Info

Publication number
EP2484404B1
EP2484404B1 EP12164364.7A EP12164364A EP2484404B1 EP 2484404 B1 EP2484404 B1 EP 2484404B1 EP 12164364 A EP12164364 A EP 12164364A EP 2484404 B1 EP2484404 B1 EP 2484404B1
Authority
EP
European Patent Office
Prior art keywords
braid
sheath
placing
over
spring reinforcement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP12164364.7A
Other languages
German (de)
English (en)
Other versions
EP2484404A1 (fr
Inventor
John R Brustad
Payam Adlparvar
Wassim R Aliahmad
Canh T Tran
Nabil Hilal
Boun Pravong
Raffi S Pinedjian
Charles C Hart
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Applied Medical Resources Corp
Original Assignee
Applied Medical Resources Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Applied Medical Resources Corp filed Critical Applied Medical Resources Corp
Publication of EP2484404A1 publication Critical patent/EP2484404A1/fr
Application granted granted Critical
Publication of EP2484404B1 publication Critical patent/EP2484404B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • A61M25/0012Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/001Combinations of extrusion moulding with other shaping operations
    • B29C48/0011Combinations of extrusion moulding with other shaping operations combined with compression moulding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/001Combinations of extrusion moulding with other shaping operations
    • B29C48/0021Combinations of extrusion moulding with other shaping operations combined with joining, lining or laminating
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/15Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
    • B29C48/154Coating solid articles, i.e. non-hollow articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/15Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor incorporating preformed parts or layers, e.g. extrusion moulding around inserts
    • B29C48/156Coating two or more articles simultaneously
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C53/00Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/56Winding and joining, e.g. winding spirally
    • B29C53/58Winding and joining, e.g. winding spirally helically
    • B29C53/60Winding and joining, e.g. winding spirally helically using internal forming surfaces, e.g. mandrels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C61/00Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor
    • B29C61/006Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor the force created by the liberation of the internal stresses being used for compression moulding or for pressing preformed material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00Tubular articles

Definitions

  • This invention generally relates to a method of manufacturing a kink-resistant surgical access devices adapted to introduce surgical instrumentation into body conduits and methods of making same.
  • Surgical access devices such as sheaths and catheters have long been used to access body conduits.
  • Surgical access devices typically include an access sheath and an obturator or dilator inserted therethrough to facilitate introduction of the access sheath into a body conduit.
  • the obturator is removed leaving a working channel for fluid delivery, fluid recovery, implant delivery and, on many occasions, they provide an access pathway for an instrument such as an endoscope. It follows that such a sheath needs to be as durable and flexible as possible. A serious problem arises when an access sheath is bent or twisted causing the sheath to kink.
  • a kinked sheath is useless because it cannot communicate and because it will not allow the passage of an instrument such as a guidewire or an endoscope.
  • a kinked sheath may allow an endoscope or other device to puncture the wall. This could present a danger to the body conduit into which the sheath has been inserted. Consequently, the kinked sheath must be removed and/or replaced. As such, there has been a need in the art for an access sheath having a kink-resistant construction.
  • 5,380,304 (the '304 patent) and 5,700,253 (the '253 patent) attempt to address the kinking problem by disclosing a sheath comprising an inner tube, a flat wire coil compression fitted around the inner tube, and an outer tube connected to the inner tube through the spacings between the wire coil.
  • the outer surface of the inner tube is chemically etched to form a rough outer surface to which the outer tube is mechanically connected using a heat shrinking and formation process.
  • the present access sheath has been provided in the form of an elongate tube that has tended to migrate distally and, in some cases, have disappeared beneath the body conduit such as the urethral meatus.
  • U.S. Patent Appl. No. 09/882,630 (Publication No. 2002/0038115 A1 ) addresses this problem by providing an access sheath having an enlargement at the proximal end to prevent migration and to facilitate the insertion and removal of instrumentation.
  • the sheath includes a handle structure at the proximal end that is sized and shaped to accommodate engagement by a user's hand disposed in its natural position with the palm facing the user.
  • the handle has a funnel structure that facilitates the introduction of instrumentation into the working channel of the sheath.
  • the sheath is positioned in a relatively stationary orientation during the insertion and removal of instrumentation.
  • these sheaths with handle structures at the proximal ends have large openings and, therefore, it would be desirable to provide a mechanism such as a cap that releasably attaches to the handle structure to further facilitate use with the surgical instruments.
  • WO 01/66176 discloses the manufacturing of a sheath by assemblying a braid and a stiff coil on a core.
  • the completed sheath further comprises inner and outer layers.
  • the plastic material is preferably polyurethane but may be a thermoplastic, thermoset or any plastic material having hard and/or soft durometer.
  • a wire is alternatively wound around a mandrel in a multifilar fashion with a filament comprising a material different from the plastic coating of the wire.
  • a mandrel may be used as part of an extrusion process. In this process of manufacturing a kink-resistant sheath, the mandrel is coated with a first layer of plastic material to form an inner tube, a spring reinforcement is placed over the inner tube, which is then coated with a second layer of plastic material to form an outer tube of the sheath.
  • the inner tube and outer tube may be formed by either extrusion or molding.
  • the spring reinforcement may be a pre-wound wire or a wire wound around the inner tube.
  • the material of the wire, the hardness of the wire, the pitch of the windings and the shape of the wire could vary depending on the application of the sheath.
  • the wire e.g., may comprise a metallic and/or plastic material.
  • the wire may be round, rectangular, hexagonal or any other shape that facilitates interlocking of the windings.
  • another coating or outside layer could be placed over the spring reinforcement in a dipping process.
  • the spring reinforcement is then dipped in a solvent based solution to form the outer layer of the sheath.
  • This final coating could be formed on the sheath using a dipping process either in place of or in addition to the outer layer formed by extrusion. That is, the final coating could be extruded and/or dipped.
  • the braid may comprise of woven fibers made of plastic, metal or any combination of plastics and metals. The braid may be heat fused to prevent axial stretching. Furthermore, the braid may be insert molded, fused or bonded onto the sheath.
  • FIG. 1 An access sheath is illustrated in FIG. 1 and is designated generally by reference numeral 10.
  • the sheath 10 is illustrated in combination with a separate, but associated, dilator or obturator 12.
  • the sheath 10 has the general configuration of an elongate tube 14 having an axis 16 which extends between a proximal end 18 and a distal end 21.
  • a handle 23 is disposed at the proximal end 18 of the tube 14 and provides access into a working channel 25 of the tube 14.
  • the handle 23 is formed as a radial enlargement having a distally-facing surface and a proximally-facing surface.
  • the distally-facing surface has a generally concave configuration which provides a gradual enlargement inhibiting migration of the sheath 10 into a body cavity such as the ureter.
  • the concave configuration is sized to receive adjacent fingers of a user's hand disposed in its natural position, in order to facilitate the stationary orientation of the sheath 10.
  • the proximal-facing surface has a generally convex configuration providing for an increased funneling of an instrument as it is inserted into the working channel 25 of sheath 10.
  • the handle 23 has the general configuration of the bell of a horn. This configuration is not only ergonomically comfortable, but also highly practical in addressing the problems of migration, as well as instrument insertion and removal.
  • the obturator 12 will typically have the configuration of an elongate rod 30 extending between a proximal end 32 and a distal end 34.
  • a releasable mechanism 36 shaped like a cap is disposed at the proximal end 32 and a tapered tip 38 is formed at the distal end 34.
  • the obturator 12 is adapted to be inserted into the working channel 25 of sheath 10 with the releasable mechanism 36 extending proximally of the sheath 10, and the distal end 34 extending distally of the sheath 10.
  • This operative position of the obturator 12 within the sheath 10 is illustrated in the assembled view of FIG. 2 .
  • a side view of the assembled combination is illustrated in FIG. 3 .
  • the releasable mechanism 36 is provided to removably attach the obturator 12 to the handle 23 of sheath 10.
  • the obturator 12 and sheath 10 can then be passed as a single unit over an instrument such as a guidewire.
  • This arrangement precludes inadvertent advancement of the sheath 10 in front of the obturator 12, which could greatly impede proper passage of the sheath through a body cavity such as the ureter.
  • the releasable mechanism 36 is sized and shaped to fit the handle 23.
  • a surgical instrument having a releasable mechanism disposed at its proximal end may then be introduced into the sheath 10, or a separate releasable mechanism may be attached to the handle 23 to prevent passage of fluids or instrumentation.
  • the releasable mechanism 36 may have different configurations including a snap-on cap as illustrated in FIGS. 1-4 , a twist-on cap and any foreseeable releasable mechanism that fits the handle 23 of sheath 10.
  • the releasable mechanism may include additional openings such as Luerlock connectors or sidearms providing additional working channels into the sheath as illustrated in FIG. 4 .
  • the tube 14 may be formed with a spring coil to provide a high degree of kink resistance.
  • a kink-resistant design of the access sheath such as safety and easy passage of instrumentation.
  • the '304 and '253 patents disclose one such design by reinforcing the elongate tube of the access sheath with a coil.
  • the current methods of fabricating kink-resistant access sheaths are time-consuming, costly and do not provide good yields.
  • the fabricated access sheaths do not have a good shelf life. This is because the current manufacturing processes include several challenges.
  • a current manufacturing process undergoes a dipping process where (1) a mandrel is first dipped in a plastic or PVC material, (2) a wire is then wrapped or wound around the dipped mandrel, and (3) the assembly is then dipped again in the plastic or PVC material multiple times to form the access sheath. While this is a feasible method of producing a kink-resistant access sheath, it is time consuming, costly and produces undesirable yields.
  • the present invention accordingly, provides alternative methods of manufacturing kink-resistant access sheaths that are more efficient, less costly and provide better yields and improved shelf life.
  • a wire 50 is initially coated with a plastic material 52, e.g., in a coextrusion process; the coated wire 50 is then wrapped or wound on a straight or tapered mandrel 54 forming a desired reinforcement spring 56 (i.e., forming a profile of the resultant tube); after wrapping, the wound coated wire is heated until the plastic material 52 melts and bonds the windings to form the resultant tube or sheath; and once cooled, the sheath is removed from the mandrel 54. It should be noted that the wound coated wire is heated until the plastic material 52 is formed above, below and in between the wire 50.
  • the wire/plastic coextrusion may be round, have straight edges that can be laid adjacent to each other when winding or have interlocking shapes.
  • the wound coated wire may be heated in one of several ways including: (i) capturing the windings within a shrink tube 60 as illustrated in FIG. 6 and heating until the shrink tube 60 encapsulates all the windings and the sheath is formed; and (ii) using a mold to compress the windings and heating the windings until the sheath is formed.
  • the heat shrink tube or mold is then cut or removed from the sheath as illustrated in FIG. 7 . That is, after the plastic material such as polyurethane has melted together to form the sheath with spring reinforcement, the shrink tube is cut away and the mandrel is removed.
  • the plastic material could be polyurethane, a thermoplastic, a thermoset or any plastic material having hard and/or soft durometer.
  • the coated wire could be wound onto the mandrel in a multifilar fashion with materials having alternating durometers as illustrated in FIG. 9 .
  • a wire 90 coated with a more rigid material 92 is alternatively wound with a filament 94 comprising a softer material.
  • the wound coated wire would perform like a spring coil while the softer filament would behave as the more compliant body of the tube allowing kink-resistant bending and twisting.
  • the difference in the durometer of the two materials does not need to be substantial.
  • a mandrel 100 may be used as part of an extrusion process.
  • the mandrel 100 is coated with a first layer 102 that would be the resultant internal surface of the tube.
  • a spring reinforcement 104 would then be placed over the first layer 102, and then an outer layer 106 would be extruded over the spring reinforcement 104.
  • An advantage of this is the resultant tube is not being contoured based on the process itself.
  • a contoured section could be easily added to an end of the tube providing improved movement of the tube.
  • the addition of the contoured section could be done by either insert-molding, over-molding or melding (fusing) of the contoured section to the tube.
  • the spring reinforcement 104 could be a pre-wound wire placed around the first layer 102 or a wire wrapped around the first layer 102. It is further appreciated that the gaps between the wires are filled and that the final tube has little or no voids or air bubbles.
  • another coating or outside layer 80 could be placed over the spring reinforcement by means of a dipping process.
  • the assembly is then dipped in a solvent based solution to form the outer layer 80 onto the tube or sheath.
  • the final coating could be formed on the resultant tube or sheath using a dipping process either in place of or in addition to the outer layer formed by extrusion.
  • the final coating could be extruded and/or dipped.
  • the final coating is impervious.
  • An advantage of this is it allows a layer of a desired material to be formed on the surface of the resultant tube.
  • a thin flat sheet of polyurethane having a specific width and thickness may be wrapped around the mandrel as a coating.
  • An advantage of this embodiment is it forms an even and smooth coating and it gives some control over the thickness of the coating.
  • the wire reinforcement could be pre-wound or wound during each of the above processes.
  • the material of the wire, the hardness of the wire, the pitch of the windings and the shape of the wire could vary depending on the surgical application of the tube or sheath.
  • the wire may comprise a metallic and/or plastic material.
  • the cross-section of the wire may be round, flat, hexagonal or any other shape that facilitates interlocking of the windings.
  • the use of harder or softer durometer materials is also important as to the inner or outer layer of the tube. Double reversed springs may also be used.
  • a braid such as a polyester braid may be used in addition to the coil spring to form a kink-resistant sheath as generally illustrated in FIGS. 11-15 .
  • the braid may comprise of woven fibers made of plastic, metal or any combination of plastics and metals.
  • a spring of length x is placed over a braid having a length of approximately 2x, the excess braid is then inverted over the spring to form a sheath having two layers of braid surrounding the spring.
  • the braid may be heat fused to prevent axial stretching.
  • the braid may be insert molded, fused or bonded onto the sheath.
  • FIG. 11 illustrates an exemplary braid 110 having a proximal portion 112 and a distal portion 114 with a tube 116 having a distal portion 118 and a proximal portion 120 attached to a handle 122.
  • FIG. 12 illustrates the fusing of the proximal portion 112 of braid 110 with the distal portion 118 of tube 116.
  • FIG. 12 further illustrates that the distal portion 114 of braid 110 may be insert or over-molded in a partially deployed condition, fully deployed condition or in a straight condition.
  • FIG. 13 illustrates a braid 130 and a tube 132 extruded with a plastic material 134 prior to fusing.
  • FIG. 14 illustrates the fusing of the braid 130 and tube 132.
  • FIG. 15 illustrates the coating of the braid 130 and tube 132 with a solvent based solution either by dipping or extrusion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Claims (15)

  1. Procédé de fabrication d'une gaine résistante au vrillage (10), qui comprend :
    le revêtement d'un mandrin (54) avec une première couche d'une matière plastique (134) pour former une couche interne ;
    la pose d'une tresse (130) sur la couche interne (34) ;
    la pose d'un renfort à ressort (104) sur la tresse (130) ; et
    la pose d'une deuxième couche (80) d'une matière plastique sur le renfort à ressort pour former la couche externe d'une gaine renforcée par ressort.
  2. Procédé de la revendication 1, dans lequel l'étape de pose d'un renfort à ressort (104) sur la couche interne inclut la pose du renfort à ressort sur la tresse (130).
  3. Procédé de la revendication 1 ou 2, dans lequel l'étape de pose d'une deuxième couche d'une matière plastique (80) sur le renfort à ressort pour former une couche externe inclut la pose de la deuxième couche d'une matière plastique (80) sur la tresse (130).
  4. Procédé de la revendication 1, dans lequel la tresse (130) est plus longue que le renfort à ressort (104).
  5. Procédé de la revendication 1, dans lequel le renfort à ressort (104) a une longueur x et la tresse (130) a une longueur de 2x approximativement.
  6. Procédé de la revendication 4 ou 5, qui comprend en outre l'inversion de la tresse en excès (130) sur le renfort à ressort (104).
  7. Procédé de la revendication 1, dans lequel la pose de la tresse (130) sur la couche interne (134) comprend le moulage de la tresse sur la couche interne.
  8. Procédé de la revendication 1, dans lequel la pose de la tresse sur la couche interne (134) comprend la fusion de la tresse (130) à la couche interne.
  9. Procédé de la revendication 1, dans lequel la pose de la tresse sur la couche interne (134) comprend l'adhésion de la tresse (130) à la couche interne.
  10. Procédé de l'une quelconque des revendications, dans lequel la pose d'un renfort à ressort (104) inclut la pose d'un renfort à ressort comprenant un fil ayant au moins un matériau métallique et/ou une deuxième matière plastique et ; comprenant en outre l'enroulement du renfort à ressort autour de la couche interne.
  11. Procédé de l'une quelconque des revendications précédentes, qui comprend l'immersion de la gaine dans une solution à base d'un solvant pour former la couche externe (80) de la gaine.
  12. Procédé de la revendication 1, dans lequel la tresse (130) comprend une pluralité des fibres tissées composées de plastique.
  13. Procédé de la revendication 1, dans lequel la tresse (130) comprend une pluralité des fibres tissées composées de métal.
  14. Procédé de la revendication 1, dans lequel la tresse (130) comprend une pluralité des fibres tissées composées de plastique et de métal.
  15. Procédé de l'une quelconque des revendications précédentes, dans lequel la pose d'un renfort à ressort inclut la pose d'un renfort à ressort comprenant un fil enduit ayant un matériau métallique et une deuxième matière plastique et ; comprenant en outre l'enroulement du renfort à ressort autour de la couche interne d'une manière multifiliaire avec des matériaux de durométries alternantes.
EP12164364.7A 2002-11-15 2003-11-12 Procédé de fabrication pour gaine d'accès résistante au coudage Expired - Lifetime EP2484404B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/298,116 US7005026B2 (en) 2002-11-15 2002-11-15 Kink-resistant access sheath and method of making same
EP03796398A EP1567208B1 (fr) 2002-11-15 2003-11-12 Gaine d'acces resistante au pliage et son procede de production

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP03796398A Division EP1567208B1 (fr) 2002-11-15 2003-11-12 Gaine d'acces resistante au pliage et son procede de production
EP03796398.0 Division 2003-11-12

Publications (2)

Publication Number Publication Date
EP2484404A1 EP2484404A1 (fr) 2012-08-08
EP2484404B1 true EP2484404B1 (fr) 2015-10-14

Family

ID=32297359

Family Applications (4)

Application Number Title Priority Date Filing Date
EP03796398A Expired - Lifetime EP1567208B1 (fr) 2002-11-15 2003-11-12 Gaine d'acces resistante au pliage et son procede de production
EP12164362A Expired - Lifetime EP2484403B1 (fr) 2002-11-15 2003-11-12 Gaine d'accès résistante au coudage et son procédé de fabrication
EP12164360.5A Expired - Lifetime EP2481439B1 (fr) 2002-11-15 2003-11-12 Obturateur en combinaison avec et adapté á l'insertion dans une gaine d'accès.
EP12164364.7A Expired - Lifetime EP2484404B1 (fr) 2002-11-15 2003-11-12 Procédé de fabrication pour gaine d'accès résistante au coudage

Family Applications Before (3)

Application Number Title Priority Date Filing Date
EP03796398A Expired - Lifetime EP1567208B1 (fr) 2002-11-15 2003-11-12 Gaine d'acces resistante au pliage et son procede de production
EP12164362A Expired - Lifetime EP2484403B1 (fr) 2002-11-15 2003-11-12 Gaine d'accès résistante au coudage et son procédé de fabrication
EP12164360.5A Expired - Lifetime EP2481439B1 (fr) 2002-11-15 2003-11-12 Obturateur en combinaison avec et adapté á l'insertion dans une gaine d'accès.

Country Status (5)

Country Link
US (2) US7005026B2 (fr)
EP (4) EP1567208B1 (fr)
JP (1) JP2006507055A (fr)
CA (1) CA2506240A1 (fr)
WO (1) WO2004045673A2 (fr)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6379334B1 (en) * 1997-02-10 2002-04-30 Essex Technology, Inc. Rotate advance catheterization system
WO2001023027A1 (fr) 1999-09-27 2001-04-05 Essex Technology, Inc. Systeme de catheterisation progressant par rotation
US8529719B2 (en) * 2002-11-15 2013-09-10 Applied Medical Resources Corporation Method of making medical tubing having variable characteristics using thermal winding
US20050165366A1 (en) * 2004-01-28 2005-07-28 Brustad John R. Medical tubing having variable characteristics and method of making same
US20050004515A1 (en) * 2002-11-15 2005-01-06 Hart Charles C. Steerable kink resistant sheath
US20050177185A1 (en) * 2004-02-05 2005-08-11 Scimed Life Systems, Inc. Counterwound coil for embolic protection sheath
US7691137B2 (en) * 2004-09-28 2010-04-06 Boston Scientific Scimed, Inc. Rotatable sheath, assembly and method of manufacture of same
AU2005289393B2 (en) 2004-09-28 2011-04-21 Cardinal Health 529, Llc Thin film medical device and delivery system
US8377041B2 (en) 2005-02-28 2013-02-19 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8414477B2 (en) * 2005-05-04 2013-04-09 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8343040B2 (en) * 2005-05-04 2013-01-01 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US20090005645A1 (en) * 2005-05-04 2009-01-01 Frassica James J Rotate-to- advance catheterization system
US7780650B2 (en) 2005-05-04 2010-08-24 Spirus Medical, Inc. Rotate-to-advance catheterization system
US8235942B2 (en) * 2005-05-04 2012-08-07 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8317678B2 (en) 2005-05-04 2012-11-27 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8574220B2 (en) 2006-02-28 2013-11-05 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8435229B2 (en) 2006-02-28 2013-05-07 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US8870755B2 (en) 2007-05-18 2014-10-28 Olympus Endo Technology America Inc. Rotate-to-advance catheterization system
US20080316864A1 (en) * 2007-06-25 2008-12-25 Source Of Sound Ltd. Spring based fine acoustic waveguide
US8343136B2 (en) * 2008-08-26 2013-01-01 Cook Medical Technologies Llc Introducer sheath with encapsulated reinforcing member
US7887253B2 (en) * 2008-12-23 2011-02-15 Wirtgen Gmbh Jolting device
AU2012230966B2 (en) * 2011-03-22 2017-05-11 Applied Medical Resources Corporation Method of making medical tubing having drainage holes
CN103815864A (zh) * 2014-03-17 2014-05-28 中国人民解放军第三军医大学第一附属医院 输尿管软镜的双腔工作鞘
US20160151089A1 (en) * 2014-12-02 2016-06-02 Merit Medical Systems, Inc. Distally oriented needle obturator
WO2017118948A1 (fr) * 2016-01-07 2017-07-13 Baylis Medical Company Inc. Dilatateur transseptal hybride et ses procédés d'utilisation
US10582914B2 (en) 2016-01-15 2020-03-10 Covidien Lp Navigable endobronchial tool to access tissue outside a bronchus
CN107913123B (zh) * 2016-10-11 2021-06-29 沃卡尔有限公司 通过导管输送植入物的装置和方法
EP4014830A1 (fr) * 2020-12-18 2022-06-22 Ambu A/S Endoscope et procédés de fabrication

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5131380A (en) * 1991-06-13 1992-07-21 Heller Richard M Softwall medical tube with fiberoptic light conductor therein and method of use

Family Cites Families (47)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2130586A (en) * 1936-02-18 1938-09-20 Huston Arch Charles Forming roller for tube-winding machines
US2688343A (en) * 1948-04-03 1954-09-07 Hoover Co Flexible hose
US2722263A (en) * 1951-08-17 1955-11-01 Gen Motors Corp Method of making flexible air hose
DE1281676B (de) * 1964-12-30 1968-10-31 Manfred Hawerkamp Verfahren zur Herstellung von Rohren und Behaeltern aus schraubenlinienfoermig gewickeltem Bandmaterial aus thermoplastischen Kunststoffen
US3617415A (en) * 1969-04-23 1971-11-02 Manfred Hawerkamp Method of making hollow reinforced bodies
US3988190A (en) * 1970-10-06 1976-10-26 Micropore Insulation Limited Method of forming thermal insulation materials
US3919026A (en) * 1970-10-27 1975-11-11 Kuraray Plastics Company Limit Flexible hose manufacturing process
US4010054A (en) * 1971-05-03 1977-03-01 Albert L. Jeffers Thermoplastic filament winding process
US3910808A (en) * 1972-08-30 1975-10-07 Steward Plastics Apparatus for making helically wound plastic tubing
US4078957A (en) * 1973-10-03 1978-03-14 Bradt Rexford H Filament winding apparatus and method
JPS52137715A (en) * 1976-05-13 1977-11-17 Shirou Kanao Flexible hose * having hard resin reinforcing wire
DE2711236C2 (de) * 1976-05-14 1982-09-23 Shiro Osaka Ibaragi Kanao Verfahren und Vorrichtung zum kontinuierlichen Herstellen eines Rohres
US4135869A (en) * 1977-12-05 1979-01-23 Dayco Corporation Apparatus for producing a continuous flexible tubular conduit
AU4903579A (en) * 1978-07-19 1980-01-24 Dunlop Limited Reinforced tubular articles
DE3145122C2 (de) * 1981-11-13 1984-11-29 Manfred 5210 Troisdorf Hawerkamp Vorrichtung zum Herstellen eines Rohres od. dgl. aus einem stranggepreßten thermoplastischen Kunststoffprofil
US4690175A (en) * 1981-11-17 1987-09-01 Kabushiki Kaisha Medos Kenkyusho Flexible tube for endoscope
DE3326858C1 (de) * 1983-07-26 1984-11-08 Reinhard Werner 6057 Dietzenbach Leo Vorrichtung zum Herstellen einer gewickelten Wendel
US4826423A (en) * 1987-08-19 1989-05-02 Chevron Research Company Construction of thermoplastic tubes with tubular ribs by helical winding upon a mandrel
US5125902A (en) * 1990-03-02 1992-06-30 Cardiopulmonics, Inc. Sheath/obturator to facilitate insertion of medical devices into a patient's venous system
US5092950A (en) * 1990-08-06 1992-03-03 Phillips Petroleum Company Molding method using a mandrel stabilizer
US5380304A (en) 1991-08-07 1995-01-10 Cook Incorporated Flexible, kink-resistant, introducer sheath and method of manufacture
WO1993015872A1 (fr) * 1992-02-13 1993-08-19 Navarre Biomedical, Ltd. Procede de fabrication d'un tube anti-vrillage
AU3666993A (en) 1992-02-13 1993-09-03 Navarre Biomedical, Ltd. Kink resistant tubing apparatus
USH1261H (en) * 1992-05-15 1993-12-07 Gibson Baylor D On-line consolidation of filament wound thermoplastic parts
US5472435A (en) * 1993-05-21 1995-12-05 Navarre Biomedical, Ltd. Drainage catheter
US5454790A (en) * 1994-05-09 1995-10-03 Innerdyne, Inc. Method and apparatus for catheterization access
US5454061A (en) * 1994-05-27 1995-09-26 Steward Plastics, Inc. Apparatus and method for making flexible tubing with helically wound heating conductor
US6616996B1 (en) * 1994-10-28 2003-09-09 Medsource Trenton, Inc. Variable stiffness microtubing and method of manufacture
US5676784A (en) * 1995-03-15 1997-10-14 Abbott Laboratories Method of fabricating a heater coil for a catheter used to monitor cardiac output
JP2865428B2 (ja) * 1995-04-28 1999-03-08 ターゲット セラピューティクス, インコーポレイテッド 高性能ブレードカテーテル
US5863366A (en) * 1995-06-07 1999-01-26 Heartport, Inc. Method of manufacture of a cannula for a medical device
US20010010247A1 (en) * 1995-06-07 2001-08-02 Snow David W. Cannula and method of manufacture and use
JP3855243B2 (ja) * 1996-02-21 2006-12-06 日本ゼオン株式会社 医用挿入補助具
US5846251A (en) * 1996-07-22 1998-12-08 Hart; Charles C. Access device with expandable containment member
US5971938A (en) * 1996-04-02 1999-10-26 Hart; Charles C. Access device with expandable containment member
US5836925A (en) * 1996-04-03 1998-11-17 Soltesz; Peter P. Catheter with variable flexibility properties and method of manufacture
US6306235B1 (en) 1997-10-16 2001-10-23 Nomaco, Inc. Spiral formed products and method of manufacture
US6368316B1 (en) * 1998-06-11 2002-04-09 Target Therapeutics, Inc. Catheter with composite stiffener
FR2784930B1 (fr) * 1998-10-23 2007-09-28 Vetrotex France Sa Corps de revolution creux en materiau composite et son procede de fabrication
US6471684B2 (en) 1999-04-30 2002-10-29 Appied Medical Resources Corporation Ureteral access sheath
US6139535A (en) * 1999-05-27 2000-10-31 Situs Corporation Method and apparatus for placement and activation of a medical device within a body cavity
US6213995B1 (en) * 1999-08-31 2001-04-10 Phelps Dodge High Performance Conductors Of Sc And Ga, Inc. Flexible tubing with braided signal transmission elements
EP1409058A2 (fr) * 2000-01-28 2004-04-21 William Cook Europe ApS Dispositif medical endovasculaire dote de plusieurs fils
JP3915862B2 (ja) * 2000-02-09 2007-05-16 テルモ株式会社 カテーテル
US6554820B1 (en) * 2000-03-08 2003-04-29 Scimed Life Systems, Inc. Composite flexible tube for medical applications
US6537406B1 (en) * 2000-04-03 2003-03-25 3M Innovative Properties Company Vacuum-assisted tape applicator
US7445684B2 (en) * 2003-12-11 2008-11-04 Pursley Matt D Catheter having fibrous reinforcement and method of making the same

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5131380A (en) * 1991-06-13 1992-07-21 Heller Richard M Softwall medical tube with fiberoptic light conductor therein and method of use

Also Published As

Publication number Publication date
WO2004045673A8 (fr) 2005-07-28
EP2484403B1 (fr) 2013-03-27
EP1567208A2 (fr) 2005-08-31
JP2006507055A (ja) 2006-03-02
US7005026B2 (en) 2006-02-28
CA2506240A1 (fr) 2004-06-03
US20040097881A1 (en) 2004-05-20
WO2004045673A3 (fr) 2005-06-23
EP2484403A1 (fr) 2012-08-08
US7534317B2 (en) 2009-05-19
EP2481439B1 (fr) 2016-02-03
WO2004045673A2 (fr) 2004-06-03
EP2481439A1 (fr) 2012-08-01
EP1567208B1 (fr) 2013-04-03
EP1567208A4 (fr) 2009-04-08
EP2484404A1 (fr) 2012-08-08
US20060144501A1 (en) 2006-07-06

Similar Documents

Publication Publication Date Title
US7534317B2 (en) Kink-resistant access sheath and method of making same
EP0839548B1 (fr) Cathéter de guidage à paroi mince
US6562021B1 (en) Variable stiffness electrically conductive composite, resistive heating catheter shaft
EP1787674A1 (fr) Tube de catheter pour traitement medical et sa methode de fabrication
CA2454459C (fr) Polymere integre et renfort tresse pour catheters intravasculaires
EP2018336B1 (fr) Méthode pour fabriquer une tubulure médicale ayant des caractéristiques variables utilisant un bobinnage thermique
US20060064054A1 (en) Longitudinal sheath enforcement
US20090240235A1 (en) Medical catheter tube and process for producing the same
US20070276354A1 (en) Introducer Sheath and Method for Making
EP1049951A1 (fr) Tige en fibre optique a rigidite variable
US20190143077A1 (en) Catheter devices and methods for making them
JP2001178826A (ja) カテーテル用チューブ
US20100030030A1 (en) Endoscope channel tube and method of producing the same
JP6792587B2 (ja) 医療機器および医療機器の製造方法
JP4397319B2 (ja) マイクロカテーテルの製造方法及びマイクロカテーテル
JP2001079095A (ja) カテーテルチューブ及びその製造方法
JP2006181258A (ja) マイクロカテーテルの製造方法及びマイクロカテーテル
JP4515194B2 (ja) 内視鏡可撓管および内視鏡可撓管の製造方法
JPH0747118A (ja) 補強医療外科チューブ及びその製造方法

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20120417

AC Divisional application: reference to earlier application

Ref document number: 1567208

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): DE FR GB

17Q First examination report despatched

Effective date: 20120723

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

INTG Intention to grant announced

Effective date: 20150617

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AC Divisional application: reference to earlier application

Ref document number: 1567208

Country of ref document: EP

Kind code of ref document: P

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): DE FR GB

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 13

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 60348153

Country of ref document: DE

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 60348153

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20160715

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 14

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 15

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: GB

Payment date: 20221128

Year of fee payment: 20

Ref country code: FR

Payment date: 20221123

Year of fee payment: 20

Ref country code: DE

Payment date: 20221125

Year of fee payment: 20

P01 Opt-out of the competence of the unified patent court (upc) registered

Effective date: 20230521

REG Reference to a national code

Ref country code: DE

Ref legal event code: R071

Ref document number: 60348153

Country of ref document: DE

REG Reference to a national code

Ref country code: GB

Ref legal event code: PE20

Expiry date: 20231111

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF EXPIRATION OF PROTECTION

Effective date: 20231111

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF EXPIRATION OF PROTECTION

Effective date: 20231111